What is the management approach for a 6-year-old male with recurrent otitis media (inflammation of the middle ear), allergic rhinitis, and reactive airway disease presenting with left ear discomfort and increased fluid behind the tympanic membrane (TM) without fever or active pain?

From the Guidelines

The current approach of withholding antibiotics and prescribing azithromycin to start only if fever develops or ear pain increases is appropriate for the 6-year-old boy with a history of recurrent ear infections, allergies, and reactive airway disease. The presence of fluid behind the eardrum without signs of acute infection, such as fever or ear pain, does not necessitate immediate antibiotic treatment, as indicated by the study published in 1. This approach is supported by the fact that the presence of fluid alone (serous otitis media) often resolves spontaneously and is a common finding in children with recurrent ear issues, as noted in 1. The child should continue his current antihistamine medication for allergic rhinitis management, as it helps manage the underlying allergic rhinitis, which can contribute to eustachian tube dysfunction and fluid accumulation, as discussed in 1. Some key points to consider in the management of this patient include:

• The importance of monitoring for signs of acute infection, such as fever or ear pain, and starting antibiotics if these symptoms develop
• The role of antihistamines in managing underlying allergic rhinitis and potentially reducing the risk of eustachian tube dysfunction and fluid accumulation
• The need for earwax removal to allow for better examination of the eardrum during the upcoming ENT appointment and improve hearing assessment during audiology testing
• The potential benefits and risks of surgical interventions, such as tympanostomy tube insertion, in the management of recurrent ear infections, as discussed in 1 and 1. Overall, the current approach prioritizes the child's quality of life and minimizes the risk of unnecessary antibiotic use, while also addressing the underlying allergic rhinitis and preparing for potential future interventions.

From the FDA Drug Label

Protocol 2 In a non-comparative clinical and microbiologic trial performed in the United States, where significant rates of beta-lactamase producing organisms (35%) were found, 131 patients were evaluable for clinical efficacy. The combined clinical success rate (i.e., cure and improvement) at the Day 11 visit was 84% for azithromycin. Protocol 4 In a double-blind, controlled, randomized clinical study of acute otitis media in pediatric patients from 6 months to 12 years of age, azithromycin (10 mg/kg per day for 3 days) was compared to amoxicillin/clavulanate potassium (7:1) in divided doses q12h for 10 days Each patient received active drug and placebo matched for the comparator. For the 366 patients who were evaluated for clinical efficacy at the Day 12 visit, the clinical success rate (i.e., cure plus improvement) was 83% for azithromycin and 88% for the control agent.

The patient is a 6-year-old male with a history of recurrent otitis media, and the decision was made to hold antibiotics at this time but have a prescription for azithromycin ready to start if fever develops or ear pain increases.

• Clinical Success Rate: The clinical success rate for azithromycin in the treatment of acute otitis media is around 83-84% at the Day 11-12 visit, as seen in Protocol 2 and Protocol 4 2.
• Treatment: Azithromycin can be used to treat acute otitis media in pediatric patients, including those around the age of 6 years, as demonstrated in Protocol 4 2.
• Dosage: The dosage of azithromycin used in Protocol 4 was 10 mg/kg per day for 3 days 2.

From the Research

Patient Presentation and Management

• The patient is a 6-year-old male with a history of recurrent otitis media, allergic rhinitis, and reactive airway disease, presenting with left ear discomfort.
• The patient is currently afebrile and denies ear pain in the office, but an exam shows increased fluid behind the TM.
• The decision was made to hold antibiotics at this time, but a prescription for azithromycin was sent to the pharmacy to start if fever develops or ear pain increases.

Allergic Rhinitis Management

• The patient is continuing their current antihistamine regimen for allergic rhinitis management, as supported by a study on the evidence-based use of antihistamines for treatment of allergic conditions 3.
• This study found that second-generation H1 antihistamines are safe and effective in adult and pediatric allergic rhinitis populations.

Otitis Media Treatment

• Azithromycin was chosen as the antibiotic to be used if needed, as it has been shown to be comparable to amoxicillin/clavulanate in treating otitis media in children, with fewer adverse events 4.
• Another study found that azithromycin was as effective and well-tolerated as amoxicillin/clavulanic acid in treating acute sinusitis in adults 5.

Monitoring and Follow-up

• The patient's vital signs will be monitored, and they will be reassessed if symptoms worsen, as vital signs monitoring is an important nursing assessment in detecting patient deterioration 6.
• The patient's mother was advised to contact ENT to schedule cerumen removal before the August follow-up appointment with ENT and audiology.

COVID-19 Considerations

• Although the patient does not currently have symptoms of COVID-19, such as fever or cough, it is important to note that these symptoms can be used to identify people for further testing, as they have a high sensitivity for COVID-19 7.
• However, the absence or presence of signs or symptoms is not accurate enough to rule in or rule out COVID-19, and further testing would be needed for a definitive diagnosis.